Drug Labeling and Warnings

Drug Details [pdf]

EZ2GO ZERO- dimethicone tablet 
Valley Medical Products, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Active Ingredient Section

Drug facts

Active Ingredients  (in each tablet) Simethicone 80 mg

Purpose Section

Purpose  Anti-gas

Keep Out of Reach of Children Section

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Uses Section

Uses  For the relief of pressure and bloating commonly referred to as gas.

Warnings Section

Warnings  Allergy alert: Do not take if you are allergic to simethicone.

Do not use if you have kidney disease, except under the advice or supervision of a doctor.

Ask a Doctor or Pharmacist Section

Ask a doctor before use if you have

 Nausea, vomiting or abdominal pain    A sudden change of bowel habits for over 2 weeks   irritable bowel syndrome

Ask a doctor or pharmacist before use if you are taking a prescription drug.

Pregnancy or Breast Feeding Section

If pregnant or breast feeding, ask a health professional before use.

Directions Section

Directions   Chew or swallow tablet as needed. Do not exceed 6 tablets in 24 hours except under the advise and supervision of a physician.

Other Information Section

Other information:  Each tablet contains calcium 30 mg

Tamper evident: do not use if foil has been opened.  Store at controlled room temperatures  protect from moisture

Questions or comments?

Questions or comments?

800-403-9832 or www.ez2go.com

Inactive Ingredient Section

Inactive ingredients - sucralose, lemon flavor, calcium carbonate, dextrose, flavors, maltodextrin, starch

Package Label

ez2go Zero    Relieves Gas Symptoms  Simethicone   1 DOSE 80 mg Tablet

FOLD AT LINE TEAR AT ARROW  NDC: 76470-003-03 NSF Live Safer.-    www.ez2go.com or call 800-403-9832

Doctor Recommended    User Friendly   Relieves Gas Symptoms

Manufactured, cCopyright and distributed by Valley Medical Products, LLC Ponte Verda Beach, FL 32082 USA. All rights
reserved.

EZ2GO ZERO 
dimethicone tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76470-003
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	80 mg

Inactive Ingredients
Ingredient Name	Strength
SUCRALOSE (UNII: 96K6UQ3ZD4)
CALCIUM CARBONATE (UNII: H0G9379FGK)
DEXTROSE (UNII: IY9XDZ35W2)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
STARCH, CORN (UNII: O8232NY3SJ)

Product Characteristics
Color	white (white)	Score	no score
Shape	ROUND (tablet)	Size	11mm
Flavor	LEMON (LEMON FLAVOR)	Imprint Code	VMP
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76470-003-03	1 in 1 PACKET; Type 0: Not a Combination Product	11/01/2011	04/01/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part332	11/01/2011	04/01/2015

Labeler - Valley Medical Products, LLC (969389407)

Registrant - Valley Medical Products, LLC (969389407)

Revised: 7/2019

Document Id: 8de53a10-c361-3bb3-e053-2995a90a9747

34390-5

Set id: 1e9d9786-5386-4743-92d3-75fec80e11d2

Version: 3

Effective Time: 20190717